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PHYSION® PROTOCOLS EMDA CYSTODISTENSION-ANTI-INFLAMMATORY AND GAG LAYER REPAIR A 2 STAGE PROCEDURE STAGE I

Drug Solution

Lidocaine hydrochloride 4% (NaCl- free): Epinephrine 1/1000 2.0 mg: Distilled water: Dexamethasone Sodium Phosphate: 40 mg

Catheter Electrode

: CE-DAS® UROGENICS®/ Ag 9701

Current

: 20 mA; pulse

Time of Treatment

: 20-25 min

Polarity

: POSITIVE (+)

Rise-Rate

: 30-60 A/sec

50 ml 2 ml 140 ml 10 ml 200 ml

PROCEDURE: 1.

Have the patient lie comfortably supine: Do not place in lithotomy position.

2.

Have the following 3 bowls prepared: 1st bowl : 200 ml drug solution 2nd bowl : 500 ml of bi-distilled water for bladder washing 3rd bowl : 500 ml saline solution 0.45% 1-2 50 ml syringe with conic luer.

3.

Test the catheter-balloon twice at 5 ml with air before catheterisation, following the instructions for use.

4.

Insert the CE-DAS® UROGENICS®/ Ag 9701 catheter-electrode into the bladder using conventional gel-lubricants (preferably lidocaine based, water soluble), and inflate balloon to 3 ml with air. I

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5. 6.

After flushing and draining the bladder with sterile distilled water, determine the bladder tolerance to discomfort level . Instil into the bladder the drug solution to a volume corresponding to 5-10 ml below the bladder capacity to discomfort level. (Example: capacity to discomfort level 90 ml —> instil 80-85 ml). Make sure that the balloon is within the bladder neck.

7.

Select a large area of unblemished skin on the abdomen and thoroughly "degrease" by wiping with alcohol.

8.

Wet the 2 white dispersive electrodes with saline solution 0.9%, or tap water, then cover the abdomen with a layer of 5-7 mm thick conductive gel and place the electrodes. Assure complete contact without air bubbles, by pressing and sliding gently side to side the 2 dispersive electrodes.

9.

Connect the red wire of the PHYSIONIZER® to the catheter CE-DAS® UROGENICS® and the black wire to the dispersive electrodes.

10. Follow the instructions of the PHYSIONIZER® and set all values as indicated above. Push "START" to run the treatment. 11. At intervals of 4-5 minutes add approximately 40-50 ml of the lidocaine solution with a 50 ml syringe until all 200 ml is within the bladder, then : 12. At intervals of 2-3 minutes add a quantity of 30-50 ml of sterile saline 0.45% as tolerated by the patient. The use of a 50 ml syringe is recommended to aspirate solution from the bladder to check for blood staining (barbotage). 13. The PHYSIONIZER® signals the end of EMDA with a beep. 14. Drain the bladder, measure the volume, leave the catheter in situ and move on to STAGE II.

(NB

Additional fluid (urine) appears during treatment and the quantity can vary widely. Check carefully the total amount of fluid drained.)

II

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STAGE II Drug Solution

: PENTOSAN : 200 mg diluted in : 150 ml distilled water or: HEPARIN : 15,000 units diluted in : 150 ml 0.45% saline

Current Strength

: 20-25 mA; pulse

Time of Treatment

: 20-25 min

Polarity

: NEGATIVE (-)

Rise-Rate

: 60-80 µA/sec

PROCEDURE : 1. After flushing with distilled sterile water and draining the bladder, instill the 150 ml drug solution into the bladder 2. Follow the instructions of the PHYSIONIZER and set all values as indicated above. Remember to reverse polarity from positive to negative. 3. Rotate the catheter ¼ turn every 5-7 minutes. 4. Barbotage (50 ml) every 5-7 min 5. The PHYSIONIZER signals the end of the treatment with a beep. When the treatment is finished drain the bladder and remove the catheter.

RECOMMENDED THERAPEUTIC CYCLE : 2 Treatments with an interval of approximately 14 days. ABSOLUTE CONTRAINDICATIONS - Urinary tract infection - Allergy/Idiosyncrasy to local anesthetic drugs (dental history). - Massive intravesical bleeding denoting rupture of a large vein. - Pregnancy. - Patients taking medication classified as monoamine oxidase inhibitors.

RELATIVE CONTRAINDICATIONS - Median lobe protruding into the bladder. - Strictures of the urethra or bladder neck. - Overt psychosis (1-2% patients). - Alcoholism (~1% patients)

III

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2 stage protocol